Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06842992
Eligibility Criteria:
Inclusion Criteria:
* Male and female outpatients aged 18-65 years (inclusive).
* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria ( without psychotic features).
* Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at screening and baseline visits, with item 1 (depressed mood) score ≥ 2.
* Clinical Global Impression-Severity (CGI-S) score ≥ 4 at screening and baseline.
* Negative pregnancy test for women of childbearing potential.
* Willingness to use effective contraception during the trial and for 3 months after the last dose.
* Voluntary participation and signed informed consent.
Exclusion Criteria:
* Duration of the current depressive episode in first-episode patients \< 3 months.
* Treatment-resistant depression (failure of ≥ 2 adequate antidepressant treatments).
* Other psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorders).
* History of severe neurological diseases, epilepsy, or significant head trauma.
* Unstable or severe cardiovascular, gastrointestinal, or endocrine diseases.
* History of malignancy within the past 2 years.
* History of increased intraocular pressure or untreated narrow-angle glaucoma.
* Abnormal thyroid function not adequately controlled.
* History of severe drug allergies or hypersensitivity to duloxetine or excipients.
* Suicide attempt within the past year or significant suicide risk.
* Substance abuse within the past year or positive at screening drug test.
* Alcohol abuse (≥ 14 units/week) within the past year.
* Previous treatment with duloxetine without adequate response.
* Normative use of antidepressants within 2 weeks prior to screening.
* Use of CYP2D6 or CYP1A2 potent inhibitors/inducers within 2 weeks prior to screening.
* Participation in another clinical trial within the past 3 months.
* Any condition deemed unsuitable by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06842992
Study Brief:
Protocol Section:
NCT06842992